Community Intervention and Demonstration Area Construction

Anhui Medical University

Status: Enrolling

Conditions: Myopia; Refractive Errors

Treatments: Other: Six interventions for children and adolescents

Study type: Interventional

Funder types: Other

Identifiers

NCT05715424

20210735

Details and patient eligibility

About

The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.

Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.

In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.

Enrollment: 1,000,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ● Kindergarten kids.

  • Grade of 1 to 6 in elementary schools.
  • Grade of 1 to 3 in middle schools.
  • Grade of 1 to 3 in high schools.
  • Sign the informed consent.

Exclusion criteria

• ●Visual defect or other eye diseases.

  • wearing orthokeratology; refractive surgery history.
  • Not considered suitable for inclusion in the study by the investigator.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,000,000 participants in 4 patient groups

Cluster A

Experimental group

Description:

The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years.

Treatment:

Other: Six interventions for children and adolescents

Cluster B

Experimental group

Description:

The study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years.

Treatment:

Other: Six interventions for children and adolescents

Cluster C

Experimental group

Description:

The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year.

Treatment:

Other: Six interventions for children and adolescents

Cluster D

Experimental group

Description:

The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed.

Treatment:

Other: Six interventions for children and adolescents